Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms
1 other identifier
observational
200
1 country
1
Brief Summary
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring. The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2020
CompletedFirst Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2024
CompletedAugust 17, 2021
August 1, 2021
1.8 years
June 10, 2020
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to medical treatment
Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
through study completion, an average of 1 year
Study Arms (2)
ILR Group followed with RM
Patients with unexplained syncope underwent ILR monitoring and followed with RM
ILR Group followed with in-hospital visits
Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits
Interventions
Eligibility Criteria
The study population included all patients with unexplained syncope underwent ICM implantation according to current gudelines and followed by conventionally or RM according to the hospital's clinical practice.
You may qualify if:
- Patients with unexplained syncope underwent ICM implantation according to current gudelines.
You may not qualify if:
- Patients do not provied signing Patient Informed Consent Form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campania "Luigi Vanvitelli"
Naples, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Vincenzo Russo
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 17, 2020
Study Start
May 10, 2020
Primary Completion
March 16, 2022
Study Completion
March 16, 2024
Last Updated
August 17, 2021
Record last verified: 2021-08